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Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome

NCT ID: NCT03027258

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-01-31

Brief Summary

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The investigators propose to adopt sustainable community networks (in this case churches) to implement an integrated community-based screening that incorporates mobile health technology (mHealth) to make prenatal test results available at the point-of-delivery to guide medical management.

Detailed Description

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The investigators will develop and test the feasibility, acceptability, and usability of a mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell genotype obtained from participants during the Healthy Beginning Initiative (HBI) program; store data in a secure, web-based database; encrypt data on a "smart card" which is given to participants, and make these data available at the point-of-delivery using a cell-phone application to read the "smart card". Data on the web-based database can also be accessed directly using the cell phone application. Evidence exists that when clinician have maternal records available at the point of delivery, they are more likely to initiate antiretroviral prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24 hours for infants born to women who have positive hepatitis B surface antigen and screen infants born to mothers with sickle cell trait to allow early identification and initiation of penicillin prophylaxis for infants who have sickle cell disease.

Conditions

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HIV Sickle Cell Disease Hepatitis B

Keywords

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Mobile health technology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

mHealth intervention

Group Type EXPERIMENTAL

mHealth

Intervention Type OTHER

HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.

Interventions

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mHealth

HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative
* One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease

Exclusion Criteria

* Those who do not accept to have their information uploaded on the secure database
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

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Echezona Ezeanolue

Professor of Public Health and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic Caritas Foundation

Makurdi, Benue State, Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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Echezona Ezeanolue, MD, MPH

Role: CONTACT

Phone: 7028952687

Email: [email protected]

Semiu O Gbadamosi, MD, MPH

Role: CONTACT

Phone: 7028351946

Email: [email protected]

Facility Contacts

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John Olawepo, MD, MSc

Role: primary

References

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Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.

Reference Type BACKGROUND
PMID: 23758933 (View on PubMed)

Gbadamosi SO, Eze C, Olawepo JO, Iwelunmor J, Sarpong DF, Ogidi AG, Patel D, Oko JO, Onoka C, Ezeanolue EE. A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study. J Med Internet Res. 2018 Jan 15;20(1):e18. doi: 10.2196/jmir.8716.

Reference Type DERIVED
PMID: 29335234 (View on PubMed)

Ezeanolue EE, Gbadamosi SO, Olawepo JO, Iwelunmor J, Sarpong D, Eze C, Ogidi A, Patel D, Onoka C. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol. JMIR Res Protoc. 2017 May 26;6(5):e100. doi: 10.2196/resprot.7743.

Reference Type DERIVED
PMID: 28550003 (View on PubMed)

Other Identifiers

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R21TW010252-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

820085-3

Identifier Type: -

Identifier Source: org_study_id